- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07625631
Static Ultrasound Guidance for Radial Arterial Puncture (STATIC-US)
Static Ultrasound-Guided Versus Conventional Palpation Techniques for Radial Arterial Puncture in the Emergency Department: A Randomized Controlled Trial
Radial arterial puncture is a commonly performed procedure in emergency departments for arterial blood gas analysis and invasive hemodynamic monitoring. The conventional palpation technique may be associated with prolonged procedure duration and multiple puncture attempts, particularly in patients with weak arterial pulsation or difficult vascular anatomy.
Ultrasound guidance has been proposed as a method to improve procedural success. This randomized controlled trial aimed to compare the static ultrasound-guided technique with the conventional palpation technique for radial arterial puncture in adult emergency department patients.
The primary outcome was puncture duration. Secondary outcomes included first-attempt success rate, total number of attempts, procedure-related complications, and patient pain scores.
연구 개요
상태
상세 설명
Radial arterial puncture is frequently performed in emergency departments for arterial blood gas sampling and invasive arterial pressure monitoring. Although the conventional palpation technique is widely used, procedural failure, prolonged puncture duration, and repeated attempts remain common problems, especially in patients with difficult vascular access.
Ultrasound-guided vascular access techniques have demonstrated improved success rates in several vascular procedures. However, evidence regarding the effectiveness of the static ultrasound-guided method for radial arterial puncture in emergency department settings remains limited.
This prospective randomized controlled trial was conducted in the emergency department of University of Health Sciences, Sisli Hamidiye Etfal Training and Research Hospital. Adult patients requiring radial arterial puncture were randomly assigned to either the static ultrasound-guided group or the conventional palpation group.
In the static ultrasound-guided group, the radial artery location was identified using ultrasonography prior to skin puncture, and the puncture site was marked externally. In the conventional group, arterial puncture was performed using anatomical landmarks and palpation alone.
The primary outcome of the study was puncture duration. Secondary outcomes included first-attempt success, total number of puncture attempts, procedure-related complications, and patient-reported pain scores.
The study aimed to evaluate whether the static ultrasound-guided technique could improve procedural efficiency and success compared with the conventional palpation technique in emergency department practice.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Kağıthane
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Istanbul, Kağıthane, 터키 (Türkiye), 34413
- Adem Melekoglu, MD
-
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adult patients aged 18 years and older
- Patients requiring radial arterial puncture in the emergency department
- Patients who provided informed consent
Exclusion Criteria:
- Patients younger than 18 years
- Known vascular abnormalities or previous vascular surgery involving the puncture site
- Local infection or skin lesion at the puncture site
- Hemodynamic instability requiring immediate intervention
- Inability to provide informed consent
- Previous enrollment in the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Static Ultrasound-Guided Group
Participants underwent radial arterial puncture using the static ultrasound-guided technique.
The radial artery was identified with ultrasonography prior to puncture, and the puncture site was externally marked before needle insertion.
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Static ultrasound guidance was used to identify and externally mark the radial artery location prior to arterial puncture.
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|
활성 비교기: Conventional Palpation Group
Participants underwent radial arterial puncture using the conventional palpation technique based on anatomical landmarks and arterial pulse palpation.
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Radial arterial puncture was performed using anatomical landmarks and palpation without ultrasound guidance
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Puncture Duration
기간: Immediately after the procedure
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Immediately after the procedure
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Puncture Duration
기간: At completion of the arterial puncture procedure or after a maximum of three puncture attempts
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Time required to successfully complete radial arterial puncture, measured from skin contact of the needle to successful arterial blood aspiration.
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At completion of the arterial puncture procedure or after a maximum of three puncture attempts
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
First-Attempt Success Rate
기간: During the procedure
|
Successful radial arterial puncture achieved on the first needle insertion attempt.
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During the procedure
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain Score
기간: Immediately after completion of the arterial puncture procedure
|
Patient-reported procedural pain measured immediately after arterial puncture using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
|
Immediately after completion of the arterial puncture procedure
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- SHEAH-ED-2026-001
- 3870 (기타 식별자: Sisli Hamidiye Etfal Clinical Research Ethics Committee)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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